On June 15, 2018 MEI Pharma, Inc. (NASDAQ: MEIP) a pharmaceutical company focused on leveraging its extensive development and oncology expertise to identify and advance new therapies for cancer, reported that results from a Phase 1b study of ME-401 in patients with relapsed or refractory follicular lymphoma (FL), chronic lymphocytic lymphoma (CLL) and small lymphocytic lymphoma (SLL) are being presented during a poster presentation today, Friday, June 15, 2018 at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, Sweden (Press release, MEI Pharma, JUN 15, 2018, View Source [SID1234527351]). Complete data results on the Phase 1b study were previously announced at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago in June 2018.
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"The data demonstrates that ME-401 achieved a 90% response rate across all patient groups treated and was generally well tolerated with no dose-limiting toxicities identified at any dose level," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "The full data from our ME-401 study is very encouraging and we expect to initiate a registration study for ME-401 this year for the treatment of adults with relapsed or refractory FL."
ME-401 is being evaluated in a Phase 1b dose escalation study in patients with relapsed or refractory FL, CLL and SLL. As of May 14, 2018, 46 patients were enrolled: 31 patients received monotherapy and 30 were evaluable for efficacy (12 patients at 60 mg, 12 patients at 120 mg and six patients at 180 mg). Based on the data, the Company determined that no further dose escalation was required. An expansion cohort of up to 30 patients with FL, CLL and SLL was added to further evaluate the safety and efficacy of ME-401 as a single agent at the 60 mg dose. An additional 15 patients are enrolled in the study arm evaluating ME-401 (60 mg) in combination with rituximab (marketed as Rituxan) in patients with various B cell malignancies.
The ME-401 EHA (Free EHA Whitepaper) 2018 poster can be accessed on the MEI Pharma website.